Regeneron Pharmaceuticals, Inc. announced a strategic in-licensing agreement with Hansoh Pharmaceuticals Group Company Limited (“Hansoh”) to acquire exclusive clinical development and commercial rights outside of the Chinese Mainland, Hong Kong and Macau for a dual GLP-1/GIP receptor agonist currently in Phase 3 testing. This novel therapeutic candidate (HS-20094) – studied in over 1,000 patients and administered as a weekly subcutaneous injection – has demonstrated promising efficacy and safety clinical data, suggesting a potentially similar profile to the only FDA-approved GLP-1/GIP receptor agonist. A Phase 3 trial in obesity in China and Phase 2b study in diabetes are ongoing.
Under the terms of the agreement, Regeneron will make an upfront payment to Hansoh of $80 million, with potential additional payments of up to $1.93 billion for achievement of development, regulatory and sales milestones. Future potential royalties for global net sales outside of the designated territories would be in the low double digits.
“Regeneron is committed to advancing better obesity treatments by enhancing quality of weight loss,” said George Yancopoulos, M.D., Ph.D., co-Chair, President and Chief Scientific Officer of Regeneron. “Despite the transformative impact of recent weight loss therapies, significant unmet needs remain, including the ability to sustain weight loss and maintain muscle mass over time. Securing access to a GLP-1/GIP receptor agonist will increase the versatility of our clinical programs for obesity and accelerate our mission to support quality, sustained weight loss and the associated long-term health benefits.”
“In-licensing a late-stage GLP1/GIP agonist will allow us to study combinations with Regeneron’s proprietary drugs and drug candidates in order to holistically address muscle loss and potentially other comorbidities of obesity, such as cardiovascular diseases, diabetes and liver conditions,” said Boaz Hirshberg, M.D., Senior Vice President, Clinical Development, Internal Medicine at Regeneron. “This is an exciting development in our obesity work at Regeneron, which also includes the muscle-sparing Phase 2 COURAGE study investigating the addition of trevogrumab, our GDF8 antibody to semaglutide, with and without garetosmab, our anti-activin antibody. Interim data from this study was announced earlier today.”
This agreement is subject to customary closing conditions, including applicable regulatory agency clearances under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the United States.